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This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;
• trauma (including fracture or dislocation);
• spinal stenosis;
• cervical myelopathy;
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• tumor:
• pseudoarthrosis; and/or
• failed previous fusion

The Cardiff™ Anterior Cervical Plate (ACP) System is interior interbody screw fixation of the cervical spine only. The Cardiff™ ACP System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The Cardiff™ ACP System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Cardiff™ ACP System implants are manufactured from Titanium and Nitinol alloys. Fixation is provided by bone screws into the vertebral body of the cervical spine using an anterior approach.

The provided text describes a Special 510(k) submission for the Cardiff™ Anterior Cervical Plate (ACP) System. This submission is for a product line modification of an already cleared device, not an AI/ML powered medical device, and therefore does not contain information about acceptance criteria, device performance metrics, or study details typically found in submissions for such devices.

The key points from the provided text are:

• Device Type: Anterior Cervical Plate System (a physical implant for spinal fixation).
• Purpose of Submission: Special 510(k) for manufacturing process changes and addition of implant variations to an already cleared device.
• Substantial Equivalence: The submission asserts substantial equivalence to previously cleared Cardiff™ ACP System (K083338) and Sonoma™ ACP System (K032368).
• No New Clinical/Non-Clinical Testing: The document explicitly states: "No additional non-clinical testing was required to demonstrate equivalence with the previously cleared Cardiff™ or Sonoma ACP Systems." and "Engineering and Clinical rationale verified that no additional risks were introduced into the system."

Given this, I cannot provide the requested information as it pertains to AI/ML device studies (acceptance criteria, performance, sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance, training sets). This submission is for a modification to a physical implant where the changes are deemed not to alter the fundamental scientific technology and thus did not require new performance studies.

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